WFI Quality Water
Water for Injection Quality (EP/USP, GMP)
Water-for-Injection-quality water, GMP, meeting European & US Pharmacopoeia (EP/USP) · RNase-/DNase-free available
WFI Quality Water is a GMP, Water-for-Injection-quality water meeting the European and US Pharmacopoeia (EP/USP). WFI Quality Water is manufactured in our new GMP-compliant facility in Germany by reverse osmosis, electrodeionization and ultrafiltration, meeting European and United States Pharmacopoeia (EP/USP) requirements — the highest compendial purity, ideally suited to GMP-regulated environments and sensitive upstream and downstream processes.
Why WFI Quality Water
- EP/USP quality — Water for Injection quality, meeting European and US Pharmacopoeia.
- GMP-made — manufactured under GMP in Germany.
- RNase-/DNase-free — variant available for molecular and advanced-therapy work.
- Up- & downstream — suited to sensitive regulated processes.
- Documented — batch-controlled with full documentation.
- Scalable supply — for research through commercial manufacturing.
Specifications at a glance
| Property | Detail |
|---|---|
| Water grade | WFI quality (GMP) |
| Standard | EP / USP |
| Production | Reverse osmosis · electrodeionization · ultrafiltration |
| Nuclease | RNase-/DNase-free variant available |
| Facility | GMP-compliant, Germany |
For beyond-compendial performance (endotoxin, TOC, conductivity, nuclease, elemental impurities) with a filed FDA DMF, see WFI Beyond.
Ordering & grades
| Grade | Catalogue no. | Size | Use |
|---|---|---|---|
| GMP | — to confirm — | bottles & bags | GMP / regulated use |
View in the shopRequest specification / CoA
Applications
- Upstream: cell suspensions, media preparation, reagent reconstitution, sanitization
- Downstream: buffer preparation (dilution & purification), final rinse, cleaning solutions
- Molecular biology (RNase-/DNase-free): diagnostics, PCR, RNA/DNA sequencing, in-vitro transcription, cDNA synthesis
- Gene therapy and CRISPR/Cas9 buffer preparation
Key terms
| Term | Meaning |
|---|---|
| WFI | Water for Injection — the pharmacopoeial grade of water permitted in injectable medicines (Ph. Eur. monograph 0169). |
| Endotoxin | Pyrogenic fragments of bacterial cell walls; the Ph. Eur. WFI limit is < 0.25 EU/mL. |
| TOC | Total organic carbon — a measure of organic purity; the WFI monograph limit is 0.5 mg/L. |
| Nuclease-free | No detectable RNase or DNase activity — protects RNA/DNA and mRNA payloads. |
| ICH Q3D | The international guideline that sets safe limits for 24 elemental (metal) impurities in medicines. |
| SAL 10⁻⁶ | Sterility Assurance Level of one-in-a-million — the pharmaceutical standard for terminal sterilisation. |
| DMF | Drug Master File — confidential data filed with the FDA that a customer references in their own submission via a letter of authorization. |
| GMP (EU Annex 1) | Good Manufacturing Practice for the manufacture of sterile medicinal products in the EU. |
Frequently asked questions
Is WFI Quality Water GMP?
Yes. It is manufactured under GMP in Germany and meets EP/USP requirements for Water for Injection quality.
Is it RNase-/DNase-free?
An RNase-/DNase-free variant is available for molecular-biology and advanced-therapy applications.
How does it differ from WFI Beyond?
WFI Quality Water meets the EP/USP WFI monograph. WFI Beyond is controlled beyond the monograph on endotoxin, organic carbon, conductivity, nuclease activity and elemental impurities, and is backed by a filed FDA Drug Master File (MF044505).
What is it used for?
Regulated upstream and downstream processing — media and buffer preparation, final rinse, cleaning — and, in the nuclease-free variant, molecular-biology work.
Related: Sterile Water for Cell Culture · WFI Beyond · Water Solutions